Call for Urgent Regulatory Action

PIP Action Campaign has issued a Medical Devices Alert for Patients, along with this call for the withdrawal of CE approval, significant financial penalties for manufacturers and negligent Notified Bodies, major labeling and information changes to reflect the known risks associated with silicone breast implants for patients, fully funded and operational registries; and, most importantly, urgent access to care, treatment, monitoring and compensation for the women exposed to and injured by dangerous PIP implants.

Dr. Susan Wood, with George Washington University’s School of Public Health and Health Services, is a longtime champion of women’s health. The former director of policy and program development at the U.S. Department of Health and Human Services’ Office on Women’s Affairs said that unfortunately, time and time again, safety data have come up short.

“For more than 20 years, FDA has been asking manufacturers to conduct and report rigorous studies on the safety and effectiveness of breast implants. This committee is now very aware of the limitations of the current post-approval studies. This leaves us in much the same place as in 2007, or indeed as in 1992,” Wood said. “FDA approved these products by two companies contingent on adequate post-approval studies. These studies do not seem to reach the bar.”

Wood says real enforcement procedures need to be in place, including consideration of withdrawal of approval, requirements for sponsor-funded but independent research conducted for these studies, significant financial penalties, and major labeling or patient information changes.

Europe 2016

In July 2016, French and Dutch health authorities published reports which show women are still at risk from non-compliant breast implants with no convincing or reliable safety studies and confirmed links to Breast Implant Associated ALCL. Because women are not fully informed of the risks and dangers associated with implants, PIP Action Campaign has issued a Medical Devices Alert.